Adherence to Oral Antibiotics In Patients With Osteoarticular Infections

Adherence, Medication Clinical Trial

— OBSAIO  

Official title:

Pilot Study on the ADherence to Oral Antibiotics in Patients With BONE and Joint Infections (ADABONE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311113
• Other study ID #: 69HCL17_0467
• Status: Completed
• Start date: November 16, 2017
• Est. completion date: November 15, 2018

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Bone and joint infection (BJI) are bacterial infections that can occur after surgery (nosocomial infections) or de novo. They constitute a public health problem in Western Countries . These infections are often difficult to treat, with a high rate of re-hospitalizations (19.5%) caused by relapses or recurrences. The treatment of Bone and joint infection can be surgical and / or pharmacological . Drug treatment is based on the use of parenteral and / or oral antibiotics. It is a curative therapy in most cases, with a prolonged duration ranging from 6 weeks to several months depending on the lesions .

Medication adherence, is a patients' behavior defined as drug intake with optimal attendance and regularity, as prescribed and explained by the physician. It is a key factor in the success of any drug therapy, as drugs don't work in patients who don't take them..

To the knowledge of investigators, there are no published data on the adherence to antibiotic therapy in patients treated for Bone and joint infection. In addition to its prolonged duration, the antibiotic treatment of the Osteoarticular Infections may require several daily drug intakes and may be responsible for severe adverse effects, these three factors being known to adversely affect adherence.

Prevalence, adherence patterns over time and determinants of adherence in this patient population are not known. Currently, drug adherence is not routinely evaluated and is not considered in the treatment of Bone and joint infection in the Regional Center for Complex Bone and joint infection of the investigators.

A specific study evaluating adherence to antibiotic therapy in patients treated for Bone and joint infection appears to be justified.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Affiliation having a social security

• Diagnosis of Bone and joint infections

• Surgical and clinical management of the infection at Hospices Civils de Lyon

• Oral antibiotic therapy prescribed for a minimal duration of six weeks and a defined duration

• Patient's information given and informed consent obtained

Exclusion Criteria:

• Oral antibiotic therapy for Bone and joint infections with no defined duration (chronic therapy)

• Antibiotic therapy for Bone and joint infections administered by parenteral route only

• Patient without a phone number or refusing to communicate by phone

• Patient with physical or mental disability impeding information and consent

• Patient with physical or mental disability impeding communication by phone

Related Conditions & MeSH terms

• Adherence, Medication
• Arthritis, Infectious
• Bone and Joint Infection
• Communicable Diseases
• Infection

Intervention

Other:
• Drug adherence questionnaire
Adherence to oral antibiotic therapy will be assessed by means of a questionnaire adapted from the French standardized self-assessment questionnaire of Girerd et al. This questionnaire has six questions, each question being associated with a score. Patient's drug adherence is classified into three groups based on the total score: of high, moderate and poor adherence. The questionnaire will be carried by a phone call to the patient.

Locations

Country	Name	City	State
France	Centre de référence des infections ostéo-articulaires de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with high, moderate and poor adherence	Adherence will be assessed using a questionnaire adapted from the questionnaire of Girerd et al. with 6 questions. Adherence will be assessed during the antibiotic treatment, after 6 weeks of therapy in all patients included. For the included patients still treated at 3 months, it will be evaluated a second time at 3 months.	3 months